The Recall Desk

Hazard

Sterility recalls

2,384 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,384
Critical
1
Severe
2,114
Most recent
2026-09-09

Of the 2,384 sterility recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,114 (89%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

2026–2050 of 2384

  • SevereFDA (Drugs)·D-1455-2014·2014-07-30

    Trinity Care Solutions Recalls Pfizerpen Due to Sterility Concerns

    Trinity Care Solutions is recalling 7 units of Pfizerpen (penicillin G) compounded in Florida due to quality control concerns regarding sterility assurance.

    Product
    Pfizerpen (penicillin G) 24 MU/300 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29183, Discard After 05/21/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1470-2014·2014-07-30

    Trinity Care Solutions Recalls ANA Kit Due to Sterility Concerns

    Trinity Care Solutions is recalling ANA Kits due to quality control concerns identified during an FDA inspection regarding the assurance of sterility.

    Product
    ANA Kit, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28838, Discard After 03/4/15
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1482-2014·2014-07-30

    Trinity Care Solutions Recalls Ceftriaxone Due to Sterility Concerns

    Trinity Care Solutions is recalling 12 units of Ceftriaxone 1 gm/50 mL D5W in Florida due to quality control concerns identified during an FDA inspection.

    Product
    Ceftriaxone 1 gm/50 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29190, Discard After 05/23/14, Rx # 29068, Exp 05/18/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1472-2014·2014-07-30

    Trinity Care Solutions Recalls Vancomycin Due to Sterility Concerns

    Trinity Care Solutions is recalling 21 units of Vancomycin 1 gm/100 mL 0.9%NS due to quality control concerns identified during an FDA inspection.

    Product
    Vancomycin 1 gm/100 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29186, Discard After 05/22/14; Rx # 29010, Discard After 05/22/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1481-2014·2014-07-30

    Trinity Care Solutions Recalls Cefepime Due to Sterility Concerns

    Trinity Care Solutions is recalling 11 units of Cefepime 2 gm/100 mL 0.9%NS due to quality control concerns identified during an FDA inspection.

    Product
    Cefepime 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28879, Discard After 05/21/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1465-2014·2014-07-30

    Trinity Care Solutions Recalls Impipenem/Cilastin Due to Sterility Concerns

    Trinity Care Solutions is recalling 21 units of Impipenem/Cilastin (Primaxin) 500 mg/100 mL due to quality control concerns identified during an FDA inspection.

    Product
    Impipenem/Cilastin (Primaxin) 500 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #28694, Discard After 05/22/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1480-2014·2014-07-30

    Trinity Care Solutions Recalls Ceftriaxone Due to Sterility Concerns

    Trinity Care Solutions is recalling 5 units of Ceftriaxone 2 gm/100 mL D5W due to quality control concerns identified during an FDA inspection.

    Product
    Ceftriaxone 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29150, Discard After 05/17/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1454-2014·2014-07-30

    Trinity Care Solutions Recalls Vancomycin Due to Sterility Concerns

    Trinity Care Solutions is recalling 22 units of Vancomycin 750 mg/100 mL in Florida due to quality control concerns regarding sterility assurance.

    Product
    Vancomycin 750 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28289, Discard After 02/5/14; Rx # 29189, Discard After 05/23/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1456-2014·2014-07-30

    Trinity Care Solutions Recalls Desferal Sterile Compounds Due to Sterility Concerns

    Trinity Care Solutions is recalling Desferal sterile compounds due to quality control concerns identified during an FDA inspection.

    Product
    Desferal 2.5 gm/14 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28314, Discard After 05/22/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1466-2014·2014-07-30

    Trinity Care Solutions Recalls Cefazolin Due to Sterility Concerns

    Trinity Care Solutions is recalling 21 units of Cefazolin 1 gm/100 mL 0.9%NS in Florida due to quality control concerns regarding sterility assurance.

    Product
    Cefazolin 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28837, Discard After 04/11/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1460-2014·2014-07-30

    Trinity Care Solutions Recalls Invanz Due to Sterility Concerns

    Trinity Care Solutions is recalling 12 units of compounded Invanz in Florida due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Invanz (ertapenem)1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29157, Discard After 05/19/14; Rx # 29097, Discard After 05/20/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1458-2014·2014-07-30

    Trinity Care Solutions Recalls Ceftriaxone Due to Sterility Concerns

    Trinity Care Solutions is recalling 31 units of Ceftriaxone 2 gm/100 mL 0.9%NS in Florida due to quality control concerns regarding sterility assurance.

    Product
    Ceftriaxone 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, RX # 29038, Discard After 05/05/14, & 05/20/14; RX # 29204, Discard After 05/23/14; RX # 29161, Discard After 05/19/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1457-2014·2014-07-30

    Trinity Care Solutions Recalls Cefepime Sterile Compounds Due to Sterility Concerns

    Trinity Care Solutions is recalling 24 units of Cefepime 2 gm/100 mL D5W in Florida due to quality control concerns regarding sterility assurance.

    Product
    Cefepime 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28288, Discard After 02/4/14; Rx # 29176, Discard After 05/21/14; Rx # 28829, Discard After 05/17/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1474-2014·2014-07-30

    Trinity Care Solutions Recalls Vancomycin Due to Sterility Concerns

    Trinity Care Solutions is recalling 16 units of Vancomycin 750 mg/150mL D5W due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Vancomycin 750 mg/150mL D5W,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28878, Discard After 05/16/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1433-201·2014-07-23

    Hospira Recalls Fentanyl Citrate Injection Due to Sterility Concerns

    Hospira is recalling 47,400 vials of Fentanyl Citrate Injection because loose or missing vial crimps raise concerns about sterility.

    Product
    FENTANYL CITRATE — FENTANYL CITRATE (FENTANYL CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1407-2014·2014-07-02

    Caraco Recalls Gemcitabine Injection Due to Sterility Assurance Concerns

    Caraco Pharmaceutical Laboratories is recalling 200 vials of Gemcitabine For Injection USP due to a lack of assurance of sterility.

    Product
    Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd, Gujarat, India, NDC 47335-154-40
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1393-2014·2014-06-25

    John W Hollis Inc Recalls MIC Plus B12 Injectable Due to Sterility Concerns

    John W Hollis Inc is recalling MIC Plus B12 injectable vials because the products lack assurance of sterility. Consumers should stop using the affected lots immediately.

    Product
    MIC PLUS B12, Adenosine, L-Carnitine, Contains: Methionine 15mg, Choline 100mg, Inositol 50mg, B 12, 0.200mg, Adenosine 20mg, L-Carnitine 30mg/ML, 30ML MULTI DOSE VIAL, BENZYL ALCOHOL AS A PRESERVATIVE, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1405-2014·2014-06-25

    John W Hollis Inc Recalls Pyridoxine HCl Injectable Due to Sterility Concerns

    John W Hollis Inc is recalling Pyridoxine HCl 100mg injectable products because they lack assurance of sterility. Consumers should stop using the product and contact their pharmacist.

    Product
    PYRIDOXINE HCL, Pyridoxine HCl 100mg, Also Contans: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1397-2014·2014-06-25

    John W Hollis Inc Recalls Compounded Injectable Products Due to Sterility Concerns

    John W Hollis Inc is recalling specific lots of compounded injectable products containing papaverine, phentolamine, and alprostadil due to a lack of sterility assurance.

    Product
    Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 20 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1403-2014·2014-06-25

    John W Hollis Inc Recalls Compounded Injectable Products Due to Sterility Concerns

    John W Hollis Inc is recalling compounded injectable products containing papaverine, phentolamine, and alprostadil due to a lack of sterility assurance.

    Product
    Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203 615-327-3234
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1399-2014·2014-06-25

    John W Hollis Inc Recalls Compounded Injectable Products Due to Sterility Concerns

    John W Hollis Inc is recalling specific lots of compounded injectable products containing papaverine, phentolamine, and alprostadil due to a lack of assurance of sterility.

    Product
    Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 40 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1391-2014·2014-06-25

    John W Hollis Recalls Polidocanol 5% Injection Due to Sterility Concerns

    John W Hollis Inc is recalling Polidocanol 5% Solution for Injection because the company cannot ensure the product is sterile.

    Product
    Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth 9) 50 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL Vial, JOHN HOLLIS Pharmacist Inc, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1390-2014·2014-06-25

    John W Hollis Inc Recalls Cyanocobalamin Injection Due to Sterility Concerns

    John W Hollis Inc is recalling specific lots of Cyanocobalamin injection because the products lack assurance of sterility. The recall covers 2,650 mL distributed nationwide.

    Product
    CYANOCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Each mL contains: Cyanocobalamin 1000 mcg, , Also Contains: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1389-2014·2014-06-25

    John W Hollis Inc Recalls Liver Derivative Complex Injection for Sterility Concerns

    John W Hollis Inc is recalling specific lots of Liver Derivative Complex for injection due to a lack of assurance of sterility in the compounded aseptically filled products.

    Product
    Liver Derivative Complex for injection, each mL contains: Liver Derivative Complex 25.5mg, also contains: Water for Injection, Phenol 0.5%, HCl or NaOH to adjust pH, 10 mL, Compounded by Prescription: JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1216-2014·2014-04-16

    Zions RX Formulations Recalls Oxytocin Bags Due to Sterility Concerns

    Zions RX Formulations is recalling 1,495 bags of Oxytocin 30 Units in 500mL Sodium Chloride 0.9% due to a lack of assurance of sterility.

    Product
    Oxytocin 30 Units in 500mL Sodium Chloride 0.9% Bags, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
    Category
    Drug
    Distribution
    1 state